Enhanced explant processes and mechanisms for intragastric devices

ABSTRACT

A sealing device attached to an intragastric balloon device having a head flexibly attached to a body by a pivot portion, where the pivot portion provides the head with a closed state and an open state relative to the body and the intragastric device. The sealing device having one or more plugs configured to seal an aspiration port of a lumen when the head is in a closed state and further configured to release the aspiration port of the lumen when the head is in an open state.

CROSS-REFERENCE TO RELATED APPLICATION(S)

The present application is a U.S. National Phase application under 35U.S.C. 371 of International Application Serial No. PCT/US2011/026233,filed Feb. 25, 2011, which claims the benefit of U.S. Provisional PatentApplication Ser. No. 61/308,210, filed Feb. 25, 2010, the entirecontents of which are incorporated herein by reference in theirentireties.

RELATED REFERENCES

This application incorporates by reference: U.S. Pat. Pub. No.2007/0100367, published May 3, 2007; U.S. Pat. Pub. No. 2007/0100368,published May 3, 2007; U.S. Pat. Pub. No. 2007/0100369, published May 3,2007; U.S. Pat. Pub. No. 2007/0149994, published Jun. 28, 2007; U.S.Pat. Pub. No. 2008/0243071, published Oct. 2, 2008; U.S. Pat. Pub. No.2008/0319471, published Dec. 25, 2008; U.S. Pat. Pub. No. 2005/0159769,published Jul. 21, 2005; U.S. Pat. Pub. No. 2009/0048624, published Feb.19, 2009; WIPO Pub. No. WO 2007/053556, published Oct. 5, 2007; WIPOPub. No. WO 2007/053707, published Oct. 5, 2007; WIPO Pub. No. WO2007/053706, published Oct. 5, 2007; and WIPO Pub. No. WO 2007/075810,published May 7, 2007; each as if fully set forth herein in itsentirety.

BACKGROUND

This disclosure relates to implantable, expandable gastric devices. Inparticular, this disclosure relates to mechanisms and procedures forcontrolled deflation and explant of such devices.

Many conventional implantable gastric devices have a balloon filled witha biocompatible fluid. Such gastric devices are generally inserted intothe stomach when the balloon is deflated and then inflated in vivo. Thegastric devices are often left in the stomach for an extended period oftime to treat severe obesity or other conditions. The gastric devicesare eventually removed after completing the treatment or for otherreasons by deflating the balloon, grasping the gastric device with anextraction tool, and extracting the gastric device via the esophagus andmouth. Conventional gastric devices are deflated by attempting topuncture the balloon and aspirate the biocompatible fluid through aneedle.

One challenge of deflating conventional devices is that the balloon mayrupture when it is punctured by the needle. For example, the balloontypically degrades over time because stomach acids, fungi, and bacteriamay degrade the integrity of the balloon wall, and the needle puncturemay cause a degraded balloon wall to fail. Also, it is difficult tocontrol the angle between the needle and the balloon, and the needlewill tend to rip the balloon as opposed to puncturing the balloon atcertain angles. When the balloon ruptures, the biocompatible fluid isquickly expelled into the stomach, which complicates the extractionprocedure and may be uncomfortable to the patient. Furthermore, it isbelieved that uncontrolled rupture of the balloon may permit portions ofthe balloon to detach, expose interior portions of the device normallycontained within the balloon, permit the needle to undesirably engagestructures normally contained within the balloon, require additionalsteps to recover separated components of the balloon or device, or causediscomfort or injury to the patient.

Another challenge of implantable gastric devices is grasping the devicefor extraction. Several existing devices are grasped by a claw or snare.These procedures can be challenging because projections and/or otherfeatures that are easy to grasp may agitate the stomach wall. Thus,there is a need to improve the deflation and extraction of implantablegastric devices.

BRIEF DESCRIPTION OF THE DRAWINGS

Several embodiments of the present technology are described and shownwith reference to the following description taken in conjunction withthe accompanying drawings wherein like reference numerals denote likeelements.

FIG. 1 shows a perspective view of an intragastric device.

FIG. 2 shows a top view of an intragastric device.

FIG. 3 shows a sectional view of the intragastric device of FIG. 2.

FIG. 3A shows the perspective view of FIG. 1 with a cut-out showinginternal features of the intragastric device of FIG. 1.

FIG. 4 shows a sectional view of the intragastric device of FIG. 2.

FIG. 5 shows a perspective view of a sealing device in a closed state.

FIG. 6 shows a perspective view of a sealing device in a closed state.

FIG. 7 shows a side view of a sealing device in a closed state.

FIG. 8 shows a front view of a sealing device in a closed state.

FIG. 9 shows a top view of a sealing device in a closed state.

FIG. 10 shows a bottom view of a sealing device in a closed state.

FIG. 11 shows a sectional view of the sealing device of FIG. 9.

FIG. 12 shows a sectional view of the sealing device of FIG. 9.

FIG. 13 shows a perspective view of a sealing device in an open state.

FIG. 14 shows a perspective view of a sealing device in an open state.

FIG. 15 shows a side view of a sealing device in an open state.

FIG. 16 shows a front view of a sealing device in an open state.

FIG. 17 shows a top view of a sealing device in an open state.

FIG. 18 shows a bottom view of a sealing device in an open state.

FIG. 19 shows a sectional view of the sealing device of FIG. 17.

FIG. 20 shows a sectional view of the sealing device of FIG. 17.

FIG. 21 shows a perspective view of a sealing device in a closed state.

FIG. 22 shows a perspective view of a sealing device in a closed state.

FIG. 23 shows a side view of a sealing device in a closed state.

FIG. 24 shows a front view of a sealing device in a closed state.

FIG. 25 shows a top view of a sealing device in a closed state.

FIG. 26 shows a bottom view of a sealing device in a closed state.

FIG. 27 shows a sectional view of the sealing device of FIG. 25.

FIG. 28 shows a sectional view of the sealing device of FIG. 25.

FIG. 29 shows a perspective view of a sealing device in an open state.

FIG. 30 shows a perspective view of a sealing device in an open state.

FIG. 31 shows a side view of a sealing device in an open state.

FIG. 32 shows a front view of a sealing device in an open state.

FIG. 33 shows a top view of a sealing device in an open state.

FIG. 34 shows a bottom view of a sealing device in an open state.

FIG. 35 shows a sectional view of the sealing device of FIG. 33.

FIG. 36 shows a sectional view of the sealing device of FIG. 33.

FIG. 37 shows a perspective view of a sealing device in a closed state.

FIG. 38 shows a perspective view of a sealing device in a closed state.

FIG. 39 shows a side view of a sealing device in a closed state.

FIG. 40 shows a front view of a sealing device in a closed state.

FIG. 41 shows a top view of a sealing device in a closed state.

FIG. 42 shows a bottom view of a sealing device in a closed state.

FIG. 43 shows a sectional view of the sealing device of FIG. 41.

FIG. 44 shows a sectional view of the sealing device of FIG. 41.

FIG. 45 shows a partial perspective view of an intragastric device.

FIG. 46 shows a perspective view of an intragastric device with amagnified view of a sealing device and a snare device.

FIG. 47 shows a perspective view of an intragastric device with amagnified view of a sealing device.

FIG. 48 shows a partial perspective view of an endoscope with suctiondevice.

FIG. 49 shows a partial side view of an endoscope with suction device.

FIG. 50 shows a partial side view of an endoscope with suction device.

FIG. 51 shows an end view of an endoscope with suction device.

FIG. 52 shows a partial sectional view of an endoscope with suctiondevice.

FIG. 53 shows a partial sectional view of an endoscope with analternative configuration.

DETAILED DESCRIPTION

Specific details of several embodiments of the present technology aredescribed below with reference to an intragastric device with a sealingdevice and methods for implanting and explanting such devices. Althoughmany of the embodiments are described below with respect to a dualballoon intragastric device, other types of devices with only oneballoon or more than two balloons may be within the scope of thetechnology. Moreover, several other embodiments of the technology canhave different configurations, components, or procedures than thosedescribed in this section. A person of ordinary skill in the art,therefore, will accordingly understand that the technology may haveother embodiments with additional elements, or the technology may haveother embodiments without several of the features shown and describedbelow with reference to FIGS. 1-53.

Several embodiment of the present technology are directed to a sealingdevice for use with an intragastric device comprising a body fixedlyattached to an intragastric balloon device and a head attached to thebody. The sealing device can have at least one plug aligned with andconfigured to seal an aspiration port of a lumen when the plug is in aclosed state. The sealing device can be further configured to provideaccess to the lumen when the plug is in an open state (e.g., when theplug is move so as to no longer fully obstruct the lumen).

Additional embodiments of the technology are directed to an intragastricballoon device comprising a shaft having a plurality of lumens and aplurality of balloons carried by the shaft. Each balloon can befluidically coupled to a corresponding lumen of the shaft such that aninterior portion of each balloon is in fluid communication with itscorresponding lumen. The intragastric balloon device can further includea sealing device having a body fixedly attached to the shaft and/or oneof the balloons. The sealing device can also have a head attached to thebody and at least one plug configured to seal an aspiration port of oneof the lumens when the plug is in a closed state and to provide fluidicaccess to the lumen when the plug is in an open state.

Still additional embodiments of the present technology are directed to amethod of aspirating an intragastric balloon device comprising providingan endoscope device to the intragastric balloon device within a gastriccavity. The intragastric balloon device includes at least onefluid-filled balloon and a sealing device with a body fixedly attachedto the intragastric balloon device. The sealing device further includesa head attached to the body and at least one plug configured to seal anaspiration port of a lumen of the intragastric device when the plug isin a closed state and to provide fluidic access to the lumen when theplug is in an open state. The method can further comprise securing theendoscope device to at least a portion of the sealing device, moving thesealing device to an open state by removing the plug from the lumen,whereby access to fluid in the corresponding lumen is achieved, andaspirating the fluid from the at least one balloon via the lumen.

In one embodiment, an intragastric device 10 may include at least onecollapsible, space-filling component, such as a balloon. As shown inFIG. 1, a plurality of balloons (e.g., a first balloon 30 a and a secondballoon 30 b) may be fixed to a shaft 20 of the intragastric device 10.

In the particular embodiments of the technology shown in FIGS. 1-3, theintragastric device 10 may include or be configured to interface with asealing device 100 at an end of the intragastric device 10 and a plug 45at another end of the intragastric device 10. As used herein, the terms“first” and “second” can refer to “proximal” and “distal” locations,relative locations, and orientations of structures, devices, andcomponents. For example, the terms “first”, “second”, “proximal” and“distal” may be understood to refer to relative identifiers, rather thanabsolute identifiers except where expressly stated as such. As thosehaving skill in the relevant art will recognize, variation andmodification of the disclosure on the same basis is considered withinthe present disclosure.

Referring to FIG. 3, the shaft 20 of the intragastric device 10 mayinclude a plurality of lumens; each lumen can correspond to anindividual balloon of the intragastric device 10. For example, a firstlumen 40 a may provide fluid communication from a first inflation port47 a to an interior portion of the first balloon 30 a via a firstinflation opening 32 a. Likewise, a second lumen 40 b may provide fluidcommunication from a second inflation port 47 b to an interior portionof the second balloon 30 b via a second inflation opening 32 b.

According to embodiments, and as shown in FIG. 3, each lumen may have acorresponding inflation port at an end of the lumens. Inflation portsmay be configured to allow infusion of fluids into corresponding lumensand inhibit or prevent exit of fluids from the same. Inflation ports mayinclude check valves, clack valves, non-return valves, one-way valves,duckbill valves, reed valves, etc. For example, a plug 45 may bepositioned at the end of the first balloon 30 a to dispose the firstinflation port 47 a at an end of the first lumen 40 a and to dispose thesecond inflation port 47 b at an end of the second lumen 40 b.

According to embodiments, and as shown in FIG. 3, each lumen of theshaft 20 may be divided into inflation and aspiration chambers. Forexample, the first lumen 40 a may be divided into a first inflationchamber 42 a and a first aspiration chamber 44 a by a first barrier 46a. Likewise, the second lumen 40 b may be divided into a secondinflation chamber 42 b and a second aspiration chamber 44 b by a secondbarrier 46 b. Such barriers may partition a lumen into at least twoseparate chambers that may be fluidly connected via the interior portionof a corresponding balloon.

According to embodiments, each balloon may have an opening that fluidlyconnects the interior portion thereof with at least a portion of itscorresponding lumen. According to embodiments, and as shown in FIG. 3,each balloon may have a plurality of openings that connect the interiorportion thereof with disparate chambers of its corresponding lumen. Forexample, a first inflation opening 32 a may provide a fluid connectionbetween the interior of the first balloon 30 a and the first inflationchamber 42 a, and a first aspiration opening 34 a may provide a fluidconnection between the interior of the first balloon 30 a and the firstaspiration chamber 44 a.

According to embodiments, and as shown in FIGS. 3 and 3A, sleeves may beprovided, each within the interior of a balloon and covering aninflation opening. Such sleeves may provide inflation of the balloonfrom the corresponding lumen while inhibiting or preventing deflationthrough the same opening. The sleeves may wrap radially around theportion of the shaft 20 near the corresponding opening. For example, afirst sleeve 50 a may be provided within the interior portion of thefirst balloon 30 a and covering at least the first inflation opening 32a. Likewise, a second sleeve 50 b may be provided within the interiorportion of the second balloon 30 b and covering at least the secondinflation opening 32 b. The sleeves may inhibit or prevent undesirablefluid pressure on inflation ports and thereby reduce leakage andassociated issues. For example, when pressure within the balloon exceedspressure in the corresponding lumen, a sleeve may be pressed against thecorresponding opening to inhibit or prevent leakage into the lumen. Whenpressure within the lumen exceeds pressure within the correspondingballoon, a sleeve may separate from the corresponding opening and permitinfusion into the balloon via a space formed between the sleeve andshaft housing the lumen. Fluid flowing from the first inflation chamber42 a, through the first inflation opening 32 a, through a space formedbetween the first sleeve 50 a and the exterior surface of the shaft 20,and into the interior of the first balloon 30 a is shown schematicallyby flow arrows 31 a in FIG. 3. Fluid flowing from the interior of thefirst balloon 30 a, through the first aspiration opening 34 a, and intothe first aspiration chamber 44 a is shown schematically by flow arrows33 a in FIG. 3. Likewise, the second inflation opening 32 b may providea fluid connection between the interior of the second balloon 30 b andthe second inflation chamber 42 b, and the second aspiration opening 34b may provide a fluid connection between the interior of the secondballoon 30 b and the second aspiration chamber 44 b. Fluid flowing fromthe second inflation chamber 42 b, through the second inflation opening32 b, through a space formed between the second sleeve 50 b and theexterior surface of the shaft 20, and into the interior of the secondballoon 30 b is shown schematically by flow arrows 31 b in FIGS. 3 and3A. Fluid flowing from the interior of the second balloon 30 b, throughthe second aspiration opening 34 b, and into the second aspirationchamber 44 b is shown schematically by flow arrows 33 b in FIGS. 3 and3A.

According to embodiments, and as shown in FIG. 3, each lumen may have acorresponding aspiration port at an end of the lumen. Aspiration portsmay be selectively covered by the sealing device 100, as furtherdisclosed herein. For example, a first aspiration port 48 a may beprovided at a second end of the first lumen 40 a. Likewise, a secondaspiration port 48 b may be provided at a second end of the second lumen40 b.

According to embodiments, and as shown in FIG. 4, a guidewire channel112 may extend through the sealing device 100, the plug 45, and theshaft 20 of the intragastric device 10. The guidewire channel 112 may beconfigured to accommodate a guidewire for assisted delivery andmanagement of the intragastric device 10 during implant, explant, ormaintenance thereof.

According to embodiments, and as shown in FIGS. 5-8, the sealing device100 may be provided to selectably seal an end of the intragastric device10. The sealing device 100 may include a body 102 and a head 104. Thebody 102 and head 104 may be flexibly coupled together by a joint 130,such as a pivot portion, which may enable the head 104 to move relativeto the body 102 while maintaining a connection between the head 104 andthe body 102. For example, the sealing device 100 may have at least aclosed state (see FIGS. 5-8) and an open state (see FIG. 47) defined bythe location or orientation of the head 104 and associated componentsrelative to the body 102. In several embodiments, the joint 130 maycomprise a rigid, semi-rigid, or flexible material that facilitates sucha connection.

According to embodiments, and as shown in FIGS. 7 and 12, inter alia, atleast the head 104 and the body 102 may define a recess 120 therebetweenand adjacent to the joint 130, inter alia. The recess 120 may exposeinterior portions of the sealing device 100 and provide a securementlocation for devices to act upon the sealing device 100. For example,the recess 120 may facilitate operation of a snare or other device onthe sealing device 100, as disclosed further herein.

According to embodiments, and as shown in FIGS. 5-8, inter alia, aflange 106 may extend radially outward from portions of the head 104that do not otherwise exceed the circumferential limit of othercomponents, such as the body 102 and the pivot portion 130, inter alia.The flange 106 may provide increased surface area and distribute forcesapplied at the head 104 across a greater surface area. The flange 106may have a variety of geometries. For example, as shown in FIGS. 7 and8, head 104 and the flange 106 separately or together may form asubstantially smooth, convex surface which may be viewed as an arc incross-section. For example, the top surface of the head 104 may beconfigured in an arc such that imaginary extensions of such an arc atleast generally extend tangentially with a corresponding arc extendingalong the surface of nearby balloons (as shown in FIGS. 3 and 4), so asto provide a smooth transition between the outer surfaces of the head104 and the balloon 30 b. Likewise, the plug 45 can have a flat surface(or a convex surface similar to the surface of the head 104 and flange106) that substantially aligns with the nearby surface of a balloon, soas to provide a smooth transition between the outermost surfaces of theplug 45 and balloon 30 a. As also shown in FIG. 4, the shape of walls ofthe balloons 30 a and 30 b may have a constant or near constantcurvature as the surface of the balloon approaches the location of thesealing device 100 or plug 45. As shown in FIG. 4, the walls of theballoons 30 a and 30 b can be further curved proximate to the sealingdevice 100 or plug 45 so as to curve sharply towards the inside of theballoon to join to the shaft 20 at a position disposed about the body102 of the sealing device or about the base of the plug.

The balloons may be formed to present a fully-deflated state and afully-inflated state, or a series of partially-inflated or over-inflatedstates suitable for the use of the intragastric device. A fully deflatedstate disposes the balloon so that it is pressed against or disposedloosely about the surface of the shaft so as to present a low profilefor delivery. In a fully-inflated state, the balloon presents a profilein which the curvature of the surface of the balloon aligns with thecurvature of the sealing device so as to minimize inflection points. Inan over-inflated state, that balloon extends beyond the positionobserved with the fully-inflated state so as to present a balloonsurface that curves inwardly towards an inwardly disposed sealingdevice. The balloon may also be formed of a material, or reinforced witha material, that limits the inflation of the balloon to a predeterminedfully-inflated state, or that prevents further expansion of the balloononce the balloon achieves a fully-inflated state. The balloon may alsobe constructed of a flexible non-expandable material that is in a foldedstated when deflated and in a fully unfolded state when fully inflated.

According to embodiments, and as shown in FIGS. 9 and 10, inter alia,the flange 106 may include interruptions 108 or tabs around at least aportion of a perimeter of the head 104. The interruptions 108 may beconfigured to further distribute forces applied at the head 104. Theinterruptions 108 may further be configured to facilitate securement andinterfacing with a securement device such as a snare, such that aportion of the snare is disposed within an interruption. For example, asnare configured to secure by radial constriction may better secure tothe sealing device 100 by way of at least one of the interruptions 108.

According to embodiments, and as shown in FIGS. 8, 10, and 11, interalia, the sealing device 100 may include at least one plug configured tointerface with and selectively seal a corresponding lumen of theintragastric device 10. For example, a first plug 110 a may beconfigured to selectively seal the first lumen 40 a. Likewise, a secondplug 110 b may be configured to selectively seal the second lumen 40 b.At least a portion of each plug may be configured to seal at least aportion of a corresponding lumen when the sealing device 100 is in aclosed state. Plugs may be configured to leave open at least a portionof corresponding lumens when the sealing device 100 is in an open state.Accordingly, plugs may be of a rigid, semi-rigid, or flexible materialto facilitate such selective sealing. The geometry of the plugs maycorrespond to that of the lumens. For example, the plugs may havesimilar cross-sectional geometry as that of the lumens, to provideproper sealing. The size, diameter, etc. of the plugs may exceed that ofthe lumens by a margin sufficient to facilitate sealing against pressurefrom within the lumens. For example, radial pressure provided outwardlyfrom a plug against the walls of a lumen into which it is inserted mayprovide frictional forces, electrostatic forces, Van der Waals forces,or hydrogen bonding forces, inter alia, to resist pressure from withinthe lumen tending to push the plug out of the lumen.

According to embodiments, and as shown in FIGS. 13-28, the sealingdevice 100 may be provided to selectably seal an end of the intragastricdevice 10. The body 102 and head 104 may be flexibly coupled together byone or more joints 140, such as flexible struts or connectors thatextend between the body 102 and head 104. The joints 140 can moveablycouple the head 104 to the body 102 while maintaining a connectionbetween the body 102 and the head 104. For example, the sealing device100 may have at least an open state (see FIGS. 13-20) and a closed state(see FIGS. 21-28) defined by the location or orientation of head 104 andassociated components relative to body 102. Accordingly, at least thejoints 140 may be of a rigid, semi-rigid, or flexible material tofacilitate such a connection. The joints 140 may be compressible,bendable, articulated, spring-loaded, segmented, or otherwise capable ofcausing head to move from an open state to a closed state.

According to embodiments, and as shown in FIGS. 29-44, the sealingdevice 100 may be provided to selectably seal an end of the intragastricdevice 10. The body 102 and head 104 may be moveably coupled by asliding mechanism in which the first plug 110 a and the second plug 110b are configured such that the head 104 moves axially with respect tothe body 102 while maintaining a connection between the body 102 and thehead 104. For example, the sealing device 100 may have at least an openstate (see FIGS. 29-36) and a closed state (see FIGS. 37-44) defined bythe location or orientation of the head 104 and associated componentsrelative to the body 102. Accordingly, the first plug 110 a or thesecond plug 110 b may be of a rigid, semi-rigid, or flexible material tofacilitate such a connection. The first plug 110 a or the second plug110 b may be configured to slide longitudinally within the correspondinglumen. Each of the first plug 110 a and the second plug 110 b mayinclude a first channel 150 a and a second channel 150 b, respectively.The first channel 150 a and the second channel 150 b may fluidly connectan interior portion of each corresponding lumen with a space outside theintragastric balloon device 10 when the sealing device 100 is in theopen state. The first channel 150 a and the second channel 150 b mayprevent fluid connection between an interior portion of eachcorresponding lumen with the space outside the intragastric balloondevice 10 when the sealing device 100 is in the open state. The firstplug 110 a and second plug 110 b may each include a stop 111 at one end,such as a limiter or shoulder, to prevent complete removal thereof fromthe corresponding lumen (as shown in FIGS. 35 and 36) because the stop111 has a larger diameter that abuts a portion of the body 102 toprevent the disengagement of the first and second plugs 110 a and 110 bfrom the body 102. The first plug 110 a and second plug 110 b may eachinclude a collar 113 to secure the head 104 in the closed state byresisting passage thereof through a portion of the body 102 (as shown inFIGS. 43 and 44) with an interference fit that secures the collar 113within holes passing through the body 102.

According to embodiments, methods of inflating and the aspiratingballoon device 10 are disclosed. According to embodiments, theintragastric device 10 may be provided with the balloons (e.g., firstballoon 30 a and second balloon 30 b) in a deflated state. The sealingdevice 100 may be provided installed onto the intragastric device 10 andin a closed state.

According to embodiments, the intragastric device 10 may be provided toa gastric cavity of a patient and inflated. An insufflation fluid may beprovided to the balloons via inflation ports, lumens, and openings.Where sleeves (e.g., first sleeve 50 a and second sleeve 50 b) andbarriers (e.g., first barrier 46 a and second barrier 46 b) areprovided, fluid may travel from inflation chambers (e.g., firstinflation chamber 42 a and second inflation chamber 42 b) throughinflation openings (e.g., first inflation opening 32 a and secondinflation opening 32 b) and past sleeves (e.g., first sleeve 50 a andsecond sleeve 50 b) to inflate the balloons. Where aspiration openings(e.g., first aspiration opening 34 a and second aspiration opening 34 b)and aspiration chambers (e.g., first aspiration chamber 44 a and secondaspiration chamber 44 b) are provided, fluid may flow there throughduring inflation or be restricted from the same until an aspirationprocess.

According to embodiments, a method for aspirating and explantingintragastric device 10 after emplacement and inflation thereof isdisclosed. According to embodiments, and as shown in FIG. 45, anendoscope 200 may be provided to observe and interact with the sealingdevice 100 of the intragastric device 10. Where the sealing device 100is at an end of the intragastric device 10 that is distally located froman entrance point into the gastric cavity, a standard endoscope in aretroflexed position (e.g., “U-turn” shaped endoscope) may be used, asshown in FIG. 45. The endoscope 200 may provide a variety of structuresand functions, including visualization, working channels, and devices asdisclosed further herein.

According to embodiments, and as shown in FIG. 46, a snare 210 may bedeployed from the endoscope 200 and secured to at least a portion of thesealing device 100. For example, the snare 210 may be secured onto atleast one of the head 104, the flange 106, an interruption 108, and thepivot portion 130, including combinations thereof. Where initialsecurement is not satisfactory, partial securement may be used toreposition the intragastric device 10 or the sealing device 100 prior tore-securement. Those having skill in the art will recognize that avariety of devices, tools, and structures may be used to operate on thesealing device 100 from the endoscope 200. For example, the snare 210may be any snare, grasper, forceps, needle, or other securing device forinterfacing with at least a portion of the sealing device 100.

According to embodiments, and as shown in FIG. 46, the snare 210 maycause the head 104 to move relative to the body 102 such that at leastone plug is released from a sealed position within a lumen. For example,retraction of the head 104 by the snare 210 may cause the head 104 topivot about the pivot portion 130. Such action may cause the first plug110 a to be removed from within the first lumen 40 a and the second plug110 b to be removed from within the second lumen 40 b.

According to embodiments, opening at least one lumen of the intragastricdevice 10 may cause fluid from within a corresponding balloon thereof tobe capable of deflation. For example, a lumen that has been opened maybe in fluid communication with an interior portion of a balloon via anopening. According to embodiments, opening at least one lumen of theintragastric device 10 may allow self deflation of a balloon based on atendency of the balloon to contract or constrict or based on a pressuredifferential between the interior and exterior of the balloon.

According to embodiments, a suction device 220 may be provided with theendoscope 200 for operation on the intragastric device 10, as shown inFIGS. 48-52. The suction device 220 may be compatible with, attachableto, a component of, or an integral part of the endoscope 200. Forexample, the suction device 220 and endoscope 200 may provide aworkspace 250 when brought to a portion of the intragastric device 10,such as the sealing device 100, before, during, or after opening atleast one lumen of the intragastric device 10. The suction device 220may cause fluid released from the intragastric device 10 to actively orpassively be directed to a desired location (e.g., through an endoscopevacuum channel 222 or a working lumen 202 to a reservoir). Accordingly,pressure at a distal end of the suction device 220 may be managed by anyvariety of devices, such as at a proximal end of suction device 220. Thesuction device 220 may cover all or part of the exposed portions of thesealing device 100. The suction device 220 may mate onto or within atleast one lumen to controllably aspirate fluid from the intragastricdevice 10. As shown in FIG. 52, the workspace 250 may be configured tohave an internal shape or internal diameter that corresponds to theouter shape or outer diameter of the body 102, so as to facilitate thealignment of the workspace 250 with the sealing device 100 and alignmentof the working lumen 202 with the first or second lumens 40 a and 40 b.In an alternative embodiment shown in FIG. 53, the workspace 251 may beconfigured to provide an extended recess 251 a configured to accept theshape of a portion of the sealing device 100 and to provide a chamber251 b within which a negative pressure can be maintained after thesealing device 100 sealably engages an edge 252 c. The workspace 251 andrecess 251 a also facilitate the alignment of the workspace 251 with thesealing device 100, and facilitate the engagement between the endoscope200 and first and second lumens 40 a and 40 b.

According to embodiments, partial or full deflation of the intragastricdevice 10 may facilitate subsequent explant, removal, or adjustmentthereof. According to embodiments, the intragastric device 10 may beremoved along with the endoscope 200 after deflation.

According to embodiments, a kit of parts is disclosed, includingcomponents disclosed herein, for use by a user. Included in the kit maybe instructions for use.

While the method and agent have been described in terms of what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the disclosure need not be limited to thedisclosed embodiments. It is intended to cover various modifications andsimilar arrangements included within the spirit and scope of the claims,the scope of which should be accorded the broadest interpretation so asto encompass all such modifications and similar structures. The presentdisclosure includes any and all embodiments of the following claims.

It should also be understood that a variety of changes may be madewithout departing from the essence of the invention. Such changes arealso implicitly included in the description. They still fall within thescope of this invention. It should be understood that this disclosure isintended to yield a patent covering numerous aspects of the inventionboth independently and as an overall system and in both method andapparatus modes.

Further, each of the various elements of the invention and claims mayalso be achieved in a variety of manners. This disclosure should beunderstood to encompass each such variation, be it a variation of anembodiment of any apparatus embodiment, a method or process embodiment,or even merely a variation of any element of these.

Particularly, it should be understood that as the disclosure relates toelements of the invention, the words for each element may be expressedby equivalent apparatus terms or method terms—even if only the functionor result is the same.

Such equivalent, broader, or even more generic terms should beconsidered to be encompassed in the description of each element oraction. Such terms can be substituted where desired to make explicit theimplicitly broad coverage to which this invention is entitled.

It should be understood that all actions may be expressed as a means fortaking that action or as an element which causes that action.

Similarly, each physical element disclosed should be understood toencompass a disclosure of the action which that physical elementfacilitates.

Any patents, publications, or other references mentioned in thisapplication for patent are hereby incorporated by reference. Inaddition, as to each term used it should be understood that unless itsutilization in this application is inconsistent with suchinterpretation, common dictionary definitions should be understood asincorporated for each term and all definitions, alternative terms, andsynonyms such as contained in at least one of a standard technicaldictionary recognized by artisans and the Random House Webster'sUnabridged Dictionary, latest edition are hereby incorporated byreference.

Finally, all referenced listed in the Information Disclosure Statementor other information statement filed with the application are herebyappended and hereby incorporated by reference; however, as to each ofthe above, to the extent that such information or statementsincorporated by reference might be considered inconsistent with thepatenting of this/these invention(s), such statements are expressly notto be considered as made by the applicant(s).

In this regard it should be understood that for practical reasons and soas to avoid adding potentially hundreds of claims, the applicant haspresented claims with initial dependencies only.

Support should be understood to exist to the degree required under newmatter laws—including but not limited to United States Patent Law 35U.S.C 132 or other such laws—to permit the addition of any of thevarious dependencies or other elements presented under one independentclaim or concept as dependencies or elements under any other independentclaim or concept.

To the extent that insubstantial substitutes are made, to the extentthat the applicant did not in fact draft any claim so as to literallyencompass any particular embodiment, and to the extent otherwiseapplicable, the applicant should not be understood to have in any wayintended to or actually relinquished such coverage as the applicantsimply may not have been able to anticipate all eventualities; oneskilled in the art, should not be reasonably expected to have drafted aclaim that would have literally encompassed such alternativeembodiments.

Further, the use of the transitional phrase “comprising” is used tomaintain the “open-end” claims herein, according to traditional claiminterpretation. Thus, unless the context requires otherwise, it shouldbe understood that the term “compromise” or variations such as“comprises” or “comprising”, are intended to imply the inclusion of astated element or step or group of elements or steps but not theexclusion of any other element or step or group of elements or steps.

Such terms should be interpreted in their most expansive forms so as toafford the applicant the broadest coverage legally permissible.

We claim:
 1. An intragastric balloon device, comprising: a shaft havinga plurality of lumens including at least a first lumen with a firstaspiration port and a second lumen with a second aspiration port; aplurality of balloons including at least a first balloon in fluidcommunication with the first lumen and a second balloon in fluidcommunication with the second lumen; and a sealing device having a bodyattached to the shaft, a head moveably coupled to the body to movebetween a closed state and an open state, and at least a first plugprojecting from the head, wherein— the head remains coupled to the bodybetween the closed state and the open state, the first plug isconfigured to seal the first aspiration port of the first lumen againstpressure from within the first lumen when the head is in the closedstate and further configured to open the first aspiration port of thefirst lumen when the head is in the open state, and the first plugincludes a channel in fluid communication with the first lumen, wherein(a) the channel is covered by the body of the sealing device in theclosed state, and (b) the channel is exposed from the body of thesealing device in the open state.
 2. The intragastric balloon device ofclaim 1, wherein the first and second lumens have a first inflation portand a second inflation port, respectively.
 3. The intragastric balloondevice of claim 1, wherein each balloon is in fluid communication withits corresponding lumen via an inflation opening.
 4. The intragastricballoon device of claim 1, wherein each lumen is divided into aninflation chamber and an aspiration chamber by a barrier disposedbetween the inflation chamber and the aspiration chamber.
 5. Theintragastric balloon device of claim 4, wherein each balloon is in fluidcommunication with its corresponding inflation chamber via an inflationopening.
 6. The intragastric balloon device of claim 4, wherein eachballoon is in fluid communication with its corresponding aspirationchamber via an aspiration opening.
 7. The intragastric balloon device ofclaim 6, further comprising a sleeve within each balloon selectablycovering the corresponding aspiration opening thereof.
 8. Theintragastric balloon device of claim 1, further comprising a guidewirechannel extending through the shaft and the sealing device.
 9. Theintragastric balloon device of claim 1, further comprising: a secondplug attached to the shaft and opposite the sealing device; and aguidewire channel extending through the plug and the sealing device. 10.The intragastric balloon device of claim 1 wherein the first plug isconfigured to be inserted into the first lumen when the head is in theclosed state, and wherein the first plug is configured to be at leastpartially removed from the first lumen when the head is in the openstate.
 11. The intragastric balloon device of claim 1 wherein the plugis configured to slide longitudinally with respect to the first lumen.12. An intragastric balloon device, comprising: a shaft having a firstlumen with a first aspiration port and a second lumen with a secondaspiration port; a first balloon attached to the shaft and in fluidcommunication with the first lumen; a second balloon attached to theshaft and in fluid communication with the second lumen; and a sealingdevice comprising— a body attached to the shaft, a head moveably coupledto the body to move between a closed state and an open state, whereinthe head moves axially relative to the body between the closed state andthe open state, and a first plug projecting from the head, wherein thefirst plug is configured to be inserted into the first lumen to seal thefirst aspiration port against pressure from within the first lumen whenthe head is in the closed state, and wherein the first plug isconfigured to be at least partially removed from the first lumen to openthe first aspiration port when the head is in the open state.